Clinical trial · Interventional
Neoadjuvant Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients
Neoadjuvant Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients: A Single-arm Phase I Trial
NCT04473716CI-TRIAL-00071582completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to use the combination of immune checkpoint inhibitor of Toripalimab, and chemotherapy agents of TP, as a neoadjuvant therapy to treat the patients with locally advanced OSCC, followed with radical surgery and post-operative radiotherapy/chemoradiotherapy, the major pathological response and safety will be evaluated as the primary surrogate endpoints, the 2-year survival rate and local recurrence rate will be the second endpoints.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Induction Chemotherapy | — | UNRESOLVED | — |
| Inductive Therapy | — | UNRESOLVED | — |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Programmed Cell Death 1 Inhibitor | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Paclitaxcel | Drug | — | UNRESOLVED |
| Post-operative radiotherapy/chemoradiotherapy | Radiation | — | UNRESOLVED |
| Radical surgery | Procedure | — | UNRESOLVED |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant therapy with Toripalimab, Paclitaxcel and Cisplatin
- description
- Pre-operative neoadjuvant therapy will be used with the combination of immune checkpoint inhibitor of Toripalimab, and chemotherapy agents of paclitaxcel and cisplatin in patients with locally advanced OSCC. After inductive therapy, the patients will receive radical surgery and post-operative radiotherapy/chemoradiotherapy.
- interventionNames
- Drug: Toripalimab
- Drug: Paclitaxcel
- Drug: Cisplatin
- Procedure: Radical surgery
- Radiation: Post-operative radiotherapy/chemoradiotherapy
Primary outcomes (1)
- measure
- Major pathological response
- timeFrame
- One year
- description
- Major pathological response is based on the pathological examination on the post-operative specimens after neoadjuvant therapy.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern cooperative oncology group performance status (ECOG PS) score: 0-1 points * Pathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheeks, mouth floor, hard palate, posterior molar region) * Clinical stage of III/IVA (AJCC 2018) * Blood routine: white blood cells \> 3,000/mm3, hemoglobin \> 8g/L, platelets \> 80,000/mm3 * Liver function: Alanine Transaminase/Aspartate Transaminase \<2.5 times the upper limit of normal, bilirubin \<1.5 times the upper limit of normal * Renal function: serum creatinine \<1.5 times the upper limit of normal * Sign the informed consent Exclusion Criteria: * There are still unresolved toxic reactions above CTCAE level 2 caused by previous anti-cancer treatment * Grade 3-4 allergic reactions to Toripalimab, paclitaxcel or cisplatin * Active severe clinical infection (\> CTCAE 5.0 version 2 infection) * Difficult to control hypertension or cardiovascular disease with clinical significance (such as activity)-such as cerebrovascular accident (\< 6 months before treatment), myocardial infarction (\< 6 months before treatment), unstable angina, New York Cardiology Society (NYHA Appendix 5) congestive heart failure grade II or above, or severe arrhythmia that cannot be controlled with drugs or has potential impact on experimental treatment * Chronic diseases requiring immunotherapy or hormone therapy * Women during pregnancy or lactation * Participated in other clinical studies within 30 days before enrollment * Other circumstances that the investigator thinks are not suitable for participating in the study
References
Publications (1)
- DERIVEDHuang Y, Sun J, Li J, Zhu D, Dong M, Dou S, Tang Y, Shi W, Sun Q, Zhao T, Zhou Z, Zhou X, Liu Y, Li J, Zhu G, Zhang D, Chen Y, Zhu Q, Ju W, Zhong L. Neoadjuvant immunochemotherapy for locally advanced resectable oral squamous cell carcinoma: a prospective single-arm trial (Illuminate Trial). Int J Surg. 2023 Aug 1;109(8):2220-2227. doi: 10.1097/JS9.0000000000000489. PMID 37288582